RedHill Biopharma Receives Notice of Allowance for Two Additional U.S. Patents Covering BEKINDA®
RedHill received Notices of Allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102), expected to be valid until at least 2034, once granted
BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications
Top-line results from a Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017
A Phase II study with BEKINDA® 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) is ongoing, with top-line results expected in the third quarter of 2017
RedHill will host an R&D Day and live webcast on BEKINDA® on Thursday, April 27, 2017 in NYC, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively
TEL-AVIV, Israel, April 18, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has received notices of allowance from the United States Patent and Trademark Office (USPTO) for two new patents covering BEKINDA® (RHB-102)1. Once granted, the patents are expected to be valid until at least 2034.
Danielle Abramson, Ph.D., RedHill's Director of Intellectual Property & Research said: "We are very pleased with the allowance of two additional U.S. patents for BEKINDA®. This is an important addition to RedHill's strong IP portfolio, that will further enhance our protection of BEKINDA®. We are approaching significant milestones with BEKINDA® in the coming months, with top-line results from the Phase III study for gastroenteritis and gastritis expected in the second quarter of 2017 and top-line results from the Phase II for IBS-D expected in the third quarter of 2017."
The patent applications, entitled 'Antiemetic Extended Release Solid Dosage Forms' and 'Ondansetron Extended Release Solid Dosage Forms for Treating Either Nausea, Vomiting or Diarrhea Symptoms', cover claims directed to ondansetron extended release tablets and methods of treating patients with ondansetron extended release solid dosage forms. In addition to the two new U.S. patent applications, the patent portfolio covering BEKINDA® includes one U.S. patent, two pending U.S. patent applications, 17 foreign patents, and over 35 pending foreign patent applications.
BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications. BEKINDA® is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet.
Top-line results from the Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017. In February 2017, RedHill announced that the last patient had completed the treatment course and observation period in the randomized, double-blind, placebo-controlled GUARD study, which treated 320 adults and children over the age of 12 in 29 U.S. clinical sites.
A randomized, double-blind, placebo-controlled Phase II study with BEKINDA® 12 mg is currently ongoing for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 with IBS-D in 16 clinical sites in the U.S. Top-line results are expected in the third quarter of 2017.
The Phase III GUARD study and Phase II study with BEKINDA® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.
About BEKINDA® (RHB-102):
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. A Phase III clinical study of BEKINDA® 24 mg formulation for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with patient treatment course and observation period completed and top-line results expected in the second quarter of 2017. A Phase II study with BEKINDA® 12 mg formulation is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) with top-line results expected in the third quarter of 2017.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, as well as an exclusive license agreement with Entera Health for EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill's clinical-stage pipeline includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP). More information about the Company is available at: www.redhillbio.com.
